Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-58

How is it "momentous"?

"Mesoblast has now generated substantial new data which it believes establish the relevance of the
proposed in vitro immunomodulatory activity of remestemcel-L to the clinical effect of the product in
the completed Phase 3 trial in pediatric SR-aGVHD, including to survival outcomes and biomarkers of
the product’s in vivo activity. Mesoblast will provide these new data to OTAT and address other
remaining CRL items as required for the BLA resubmission.
By demonstrating the relevance of the in vitro potency assay to clinical outcomes, Mesoblast believes
it will be able to show that the remestemcel-L product used in the Phase 3 trial in pediatric SR-aGVHD
was standardized as to identity, strength, quality, purity, and dosage form, and that this will address
OTAT’s recommendation for an additional adequate and well-controlled study.
Mesoblast continues to be in a well-established process with FDA’s Center for Biologics Evaluation and
Research (CBER), and if the resubmission is accepted, CBER will consider the adequacy of the clinical
data in the context of the related CMC issues noted above

1. No dates. When did the meeting take place?
2. This is largely a re-statement of previous information. With the exception that at this meeting OTAT which took place "recently" they said the approach was "reasonable" but MSB still needs to establish the relationship between the proposed in vitro immunmodularity and the activity of remestemcel-L. So that information still needs to be provided to OTAT "and address remaining CRL items". Does that mean that another meeting with OTAT still needs to be held?